Open Medicine EU

The latest version of the EMA transparency policy gives significant weight to copyright law and intellectual property rights (IPR). In responding to the Ombudsman’s concerns about changes in its transparency policy, the agency cited a “clear message” from the Commission of the requirement to respect intellectual property rights That requirement, whatever it is, is also one of the subjects in “ongoing discussions” with the Commission on access to documents in the agency.

A few days ago, the American Chamber of Commerce published a report strongly critical of the proposed new transparency policy of the EMA (and of the EU more generally). Much of its opposition relied on arguments in relation to IPR.

Clearly, the EMA must carefully assess what precise obligations it may, or may not, have under copyright and IPR law. The way it is going about it does not inspire trust or confidence.

We don’t know precisely what conclusions the agency has come to about copyright law, we don’t know what the Commission said to the agency about copyright and IPR law and we don’t know what is being said about copyright and IPR in the ongoing discussions between the agency and the Commission about access to documents. (We don’t know either if the Management Board of the agency will have access to all the background documents when it meets to discuss the new transparency policy on 12th June.)

The new Head of Legal at the agency is Mr. Stefano Marino, who came from a long career at senior level in the industry, including seven years as Chairman of the Trademark Committee and thirteen years a member of the Intellectual Property Protection Committee of EFPIA, the pharmaceutical industry association. I’ve said before and I repeat here that I do not imply any personal impropriety or the slightest lack of integrity on Mr. Marino’s part, but there is an issue of public policy here. Has the EMA’s chief legal adviser played an important role in shaping the agency’s response to industry arguments about copyright, TRIPS and IPR – arguments that presumably he helped to shape over many years as a senior IPR expert in the industry association?

Is the EMA’s handling of this issue to date likely to increase public confidence in the agency? Emphatically not, in my opinion.

In my view, the agency should seek (and publish) independent external advice on the implications for transparency of copyright law and IPR law generally. This is no reflection on Mr. Marino – in private practice, lawyers who change employers are usually precluded for a time from dealing with issues in which they were previously involved for another interest. Something similar should be done here.

Secondly the agency should publish the advice it receives from any source, including the “clear message” from the Commission. On such a crucial and important issue, there must be full public scrutiny.

For the reasons outlined above, the Management Committee of the agency should not approve the recent changes in policy next Thursday. (A further reason is that the Ombudsman is still examining the recent practices of the agency here.)

The legal opinions and interpretations of complex law that form the basis of the agency’s new policy on transparency are not disclosed or subject to public scrutiny. This is bizarre and, to put it bluntly, mal-administration.

The current discussions behind closed doors will have wider effects. The same considerations of copyright and IPR will clearly feed into other, distinct, policy areas including access to documents, and the implementation of the new regulation on clinical trials. All the more reason for transparency. END

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